FDA Inspection
Contour Healer LLCContour Healer LLC – FDA Inspection, Sep 15, 2023
Record Details
This FDA Inspection record concerns Contour Healer LLC, with an inspection on September 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 86b17e45-518d-446d-b11b-eeec3e60e5c8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1218529
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Contour Healer LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 5, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Contour Healer LLC
- FDA Inspection 1024637 - 2017-07-20
- FDA Inspection 857050 - 2013-11-05
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